evaluation of xaluritamig in high-risk, biochemically recurrent, non-metastatic castrate-sensitive prostate cancer

Conditions: Prostate Cancer; High-risk Biochemical Recurrence; High Risk Biochemical Recurrence of Non-metastatic Castration-sensitive Prostate Cancer; Non-metastatic Castration-sensitive Prostate Cancer

Summary: the main objective of this study is to evaluate the safety and tolerability of xaluritamig monotherapy in adult participants with high-risk biochemical recurrent (bcr) nonmetastatic castration-sensitive prostate cancer (nmcspc).


Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features. * prostate cancer initially treated by radical prostatectomy (rp) or radiotherapy (xrt) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent. * psa doubling time ≤ 12 months. * participants must have biochemically recurrent disease after definitive treatment to prostate by either rp or xrt. * screening psa by the local laboratory ≥ 0.2 ng/ml for participants who had rp (with or without xrt) as primary treatment for prostate cancer or at least 2 ng/ml above the nadir (local assessments) for participants who had xrt or brachytherapy only as primary treatment for prostate cancer. * serum testosterone ≥ 150 ng/dl (5.2 nmol/l). * participants must have undergone a 68ga-psma-11 or a piflufolastat f18 pet scan during or within 3 months of screening. exclusion criteria * present evidence of metastatic disease in conventional ct scan and/or bone scan * participants that present prostate-specific membrane antigen (psma)-positive lesions in the 68ga-psma-11 or the piflufolastat f18 positron emission tomography (pet) scan may be enrolled if the conventional imaging does not show suspicion of metastatic disease. * prior hormonal therapy, exceptions include: * neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before enrollment, or * a single dose or a short course (≤ 6 months) of hormonal therapy given for rising psa ≥ 9 months before enrollment. * prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, enzalutamide, apalutamide, or darolutamide for prostate cancer. * abiraterone acetate, enzalutamide, apalutamide, or darolutamide are allowed if administered in a neoadjuvant/adjuvant setting ≤ 36 months in duration and ≥ 9 months before enrollment. * prior systemic biologic therapy, including immunotherapy, for prostate cancer. * if, in the investigator's opinion, salvage therapy is the preferred intervention. * confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. * participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment. * requirement for chronic systemic corticosteroid therapy (prednisone dose \> 10 mg/day or equivalent) or any other immunosuppressive therapies (including anti tumor necrosis factor alpha \[tnfα\] therapies).

Keywords: xaluritamig t-cell engager amg509 steap1 immunotherapy